NEAR-HOME
Research type
Research Study
Full title
Neutrophil Elastase Assay Reliability at HOME (NEAR-HOME)
IRAS ID
325135
Contact name
James D. Chalmers
Contact email
Sponsor organisation
TASC
Duration of Study in the UK
0 years, 3 months, 22 days
Research summary
Patients with bronchiectasis frequently get chest infections which can be difficult to treat. Symptoms include an increase coughing, sputum (phlegm) production and breathlessness. These symptoms can be made worse by inflammation of the airways. Neutrophils are a type of blood cell that help your body reduce this inflammation.
Neutrophil Elastase (NE) is a naturally occurring substance produced by neutrophils. NE is released by the neutrophils during inflammation and helps breakdown bacteria that cause infection. High levels of NE in sputum can help your medical team identify people who have/are at risk of developing lung infections.
The aim of the study is to see if patients can use a test called the NEATstik ® (like lateral flow test used for COVID-19) to monitor NE levels inflammation at home. Home monitoring of inflammation would be more convenient better for patients than in-hospital testing and might help identify infections more rapidly.
This is pilot, observational study at Ninewells Hospital, single site. We aim to recruit 20 people aged 18+. Patients will be asked to monitor NE levels of inflammation using the NEATstik® at home 2x week for 3 months. We will also ask them to take photographs of the NEATstik® device result and send them to the study team by a mobile phone camera. The transferred photographs will be used by the study team to rate scores so that results from both patients and study staff can be compared.
At visits 1, 3 and any unscheduled visit (for an exacerbation), patients will be asked to provide a blood and sputum sample. This will allow us to compare sputum and blood markers of inflammation from baseline up to 3 months. We will also monitor how patients are feeling by asking them to complete a Quality-of-Life questionnaire and a brief daily symptom diary.REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0078
Date of REC Opinion
17 Jul 2023
REC opinion
Further Information Favourable Opinion